Serono-Baker Diagnostics, Inc. - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Serono-Baker Diagnostics, Inc. Chemistry ✕
21 devices
Cleared
Nov 30, 1992
TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY
Chemistry
98d
Cleared
Mar 02, 1992
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE)
Chemistry
124d
Cleared
Mar 02, 1992
SRI TESTOSTERONE ENZYME IMMUNOASSAY
Chemistry
109d
Cleared
Nov 19, 1991
SR1 FREE T4 ENZYME IMMUNOASSAY
Chemistry
137d
Cleared
Oct 23, 1991
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)
Chemistry
16d
Cleared
Sep 18, 1991
SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)
Chemistry
141d
Cleared
Aug 16, 1991
SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)
Chemistry
150d
Cleared
Jul 25, 1991
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
Chemistry
62d
Cleared
May 28, 1991
SR1 ESTRADIOL ENZYME IMMUNOASSAY
Chemistry
60d
Cleared
May 24, 1991
SRI TSH IMMUNENZYMETRIC ASSAY
Chemistry
86d
Cleared
May 01, 1991
SRI T3 IMMOENZYMETRIC ASSAY
Chemistry
69d
Cleared
Jan 23, 1991
SEROZYME CORTISOL TEST KIT
Chemistry
148d
Cleared
Dec 27, 1989
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY
Chemistry
65d
Cleared
Dec 19, 1989
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
Chemistry
187d
Cleared
Oct 17, 1989
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
Chemistry
48d
Cleared
Jun 20, 1989
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
Chemistry
41d
Cleared
Jun 09, 1989
SR1 (FSH) IMMUNOENZYMETRIC ASSAY
Chemistry
56d
Cleared
Mar 08, 1989
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
Chemistry
28d
Cleared
Feb 02, 1989
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY
Chemistry
78d
Cleared
Dec 27, 1988
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY
Chemistry
49d
Cleared
Oct 31, 1988
SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER
Chemistry
76d